Next-generation NVIDIA-powered AI navigation software elevates MONARCH^TM Platform for Robotically Assisted Bronchoscopy 

Santa Clara, California -- March 12, 2025 -- Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced U.S. 510(k) regulatory clearance for MONARCH QUEST, the latest advancement in MONARCH navigation technology, featuring AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System. 

Robotically assisted bronchoscopy represents a small but fast-growing segment of lung biopsy procedures in the U.S. The MONARCH Platform, the first robotically assisted bronchoscopy system to market, provides minimally invasive access to and visualization of airways to help clinicians biopsy suspicious lung nodules. 

Nearly half of early-stage lesions are located in the periphery of the lung, which is difficult to reach with traditional bronchoscopyⁱ. The MONARCH Platform can aid clinicians in getting to an early, definitive diagnosis in lung cancer cases, which can help care teams get patients into the treatment pathway an average of three weeks fasterⁱⁱ. 

“Our goal with the MONARCH Platform is to change the treatment paradigm for diseases such as lung cancer, where significant unmet needs still remain,” said Aleksandra Popovic, President, MONARCH, Johnson & Johnson MedTech. “MONARCH QUEST demonstrates our commitment to delivering meaningful innovation that helps clinicians advance the standard of care for their patients.” 

Leveraging the power of AI for bronchoscopy 

MONARCH QUEST builds on the platform’s stable reach and precision with its unique scope-in-sheath design and continuous vision for the physician.ⁱⁱⁱ The software also integrates enhanced navigation in the MONARCH Platform with intraprocedural 3D imaging data with the potential to improve accuracy in targeting lung nodules.^iv 

MONARCH QUEST AI-powered navigation now leverages the full-stack NVIDIA accelerated computing platform, based on NVIDIA RTX^TM, increasing the platform’s real-time computational power by 260%, and allowing the system to run complex algorithms to enhance accuracy and confidence while navigating the lung. 

MONARCH QUEST also adds more AI capabilities for future software releases as the MONARCH Platform grows to meet the demand for robotically assisted bronchoscopy procedures. 

The digital capabilities in the MONARCH Platform now extend from preoperative planning through intraoperative AI-based navigation to help improve accuracy, and post-operative case data analysis. The MONARCH Platform is part of the Polyphonic™ digital ecosystem, which will connect data across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson. 

“I’m excited about using the same system in a new capacity and having more confidence in a platform I already know and trust,” said Dr. Omar Ibrahim, an interventional pulmonologist at UConn Health, who uses the MONARCH Platform in his practice. “This will really help to pinpoint and diagnose early-stage cancer.” 

About Surgical Solutions from Johnson & Johnson MedTech   

Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what’s next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction. For more, visit https://www.jnjmedtech.com/en-US/product-family/monarch. 

About Johnson & Johnson  

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Auris Health, Inc. is part of Johnson & Johnson MedTech. 

Indications for Use (United States) 
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. 

Important Safety Information 
Complications from bronchoscopy may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. More serious complications from bronchoscopy may include collapsed lung, respiratory failure, hemorrhage, burns, heart attack, or cardiac arrhythmia. 

Cautions Concerning Forward-Looking Statements 

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding MONARCH QUEST software. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Auris Health, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Auris Health, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 

Media contact:
Lindsey Diaz-MacInnis
ldiazmac@its.jnj.com

1. Murgu S, Sterman D, Yasufuku K. Demographic and lesion characteristics in the first 443 subjects enrolled in a multicenter observational real-world robotic bronchoscopy study: interim results from TARGET. Poster presented at: American Association for Bronchology and Interventional Pulmonology 2022 Annual Conference; August 11-13, 2022; Nashville, TN
2. Ost DE, Maldonado F, Shafrin J, et al. Quantifying the economic value of improvements in diagnostic accuracy of advanced bronchoscopy procedures. Am J Respir Crit Care Med. 2023;207:A4460
3. Chen A, Gillespie C. Robotic Endoscopic Airway Challenge: REACH Assessment. Ann Thorac Surg. 2018;106:296.
4. Auris, Design Verification Reports. September 2024.